Familial HyperlipidemiaNCT05767996
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
An observational study of Familial Hyperlipidemia, run by Poudre Valley Health System at 1 site in United States.
Trial summary
Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Familial Hyperlipidemia
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Elementary school children participating in baseline biometric screening, including cholesterol; with those with elevated cholesterol receiving genetic testing to identify presence/absence of FH variant
Who may be able to join
- Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant
Who cannot join
- normal cholesterol
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.
- Conditions
- Familial Hyperlipidemia
What is being measured
The primary outcome is the main question the study is designed to answer.
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
Percentage of school children who have elevated cholesterol related to FH variant
Measured: Evaluation of family members over a defined 5 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary J. Luckasen, MD, University of Colorado Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767996
- Sponsor's protocol ID
- 20-6010
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05767996
- Acronym / sponsor ID
- 20-6010
- Conditions
- Familial Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Elementary school children participating in baseline biometric screening, including cholesterol; with those with elevated cholesterol receiving genetic testing to identify presence/absence of FH variant
Key inclusion criteria (1 listed)
- Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant
Key exclusion criteria (1 listed)
- normal cholesterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
Time frame: Evaluation of family members over a defined 5 year period
Percentage of school children who have elevated cholesterol related to FH variant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Related trials for Familial Hyperlipidemia
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RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
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Active, not recruiting
Clinical Decision Support for Familial Hypercholesterolemia
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Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hyperlipidemia, run by Poudre Valley Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia (time frame: Evaluation of family members over a defined 5 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.